Technical Quality Assurance Associate & CSV Expert at Danaher - Canada

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

09 Jan, 26

Salary

0.0

Posted On

11 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software QA, Regulatory Compliance, Quality Management System, GxP, FDA 21 CFR Part 11, ISO 9001, GAMP5, Software Validation, Cross-Functional Collaboration, Training, Communication, Problem-Solving, Continuous Improvement, Documentation, Audit Support, Customer Success

Industry

Medical Equipment Manufacturing

Description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Genedata, one of Danaher’s 15+ operating companies, our work saves lives – and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. The biopharmaceutical industry is undergoing a digitalization revolution, adopting data-driven R&D approaches to develop innovative therapies quicker. Genedata’s market-leading enterprise software is fueling this revolution, enabling leading biopharma, biotech, and CRDMO companies worldwide to automate processes and leverage biopharma R&D data analytics so they can find breakthrough therapies faster. Join this digital transformation and help scientists around the world accelerate the pace of biopharma R&D. Learn about the Danaher Business System which makes everything possible. The Position: Are you passionate about software quality, regulatory compliance, and delivering impactful solutions in the life sciences industry? Genedata is seeking a Technical Software QA Associate to lead and manage quality assurance activities from a technical perspective for our Genedata Expressionist® Business Unit. In this role, you will ensure that our software meets the highest standards of quality and compliance while supporting successful delivery to customers in regulated environments, noting that this role focuses on defining and ensuring the quality assurance of the developed Expressionist product rather than software development and testing. You will oversee the continual improvement of our Quality Management System (QMS), manage software validation efforts, and collaborate closely with cross-functional teams throughout the software lifecycle. In addition to internal QA leadership, you will play a key role in supporting pre- and post-sales teams by translating user requirements into compliant, validated software solutions that meet customer needs. If you have a strong background in software QA, regulations like GxP including 21 CFR Part 11 and predicate rules, and enjoy working at the intersection of science, technology, and customer success, we’d love to hear from you. Key Responsibilities: Lead and manage all QA activities within the Genedata Expressionist Business Unit, ensuring alignment with regulatory and business objectives Continually improve and maintain effective QMS processes to enhance product quality and operational efficiency Define, review, and maintain software requirements and documentation in compliance with GxP, FDA 21 CFR Part 11, ISO, and other relevant regulations and standards Ensure full traceability from requirements through implementation and testing to support, validation and audit readiness Collaborate with cross-functional teams (Product Management, Development, DevOps, Support) to embed quality throughout the software lifecycle Provide software validation services to customers in regulated environments, including documentation, test protocols, and audit support Act as a subject matter expert on software validation and compliance in both internal and customer-facing contexts Support pre- and post-sales teams in understanding user requirements and ensuring successful software solution roll-out in regulated environments Train internal teams on compliance topics such as GxP, 21 CFR Part 11, GAMP5, and GDPR Facilitate and support internal, customer, and regulatory audits as needed Your Profile: Experience: minimum 3 - maximum 10 years in Software QA, ideally in life sciences software industries Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, ISO 9001, and GAMP5; experience with audit preparation and compliance documentation Compliance-Focused Technical Proficiency: Hands-on experience with software features that support compliance, including electronic records/signatures, audit trails, traceability, and documentation workflows Validation Expertise: Proven ability to deliver software validation services to customers, including system lifecycle documentation, test protocols, and audit support Education: Bachelor’s or Master’s degree in computer science, bioinformatics, or a degree in life sciences with a strong affinity for software/computerized systems validation Cross-Functional Collaboration: Skilled in working with product, development, DevOps, and support teams to embed quality throughout the SDLC Training & Communication: Capable of training teams on compliance topics and representing QA in customer and regulatory interactions Problem-Solving: Strong analytical mindset with the ability to manage risks, resolve issues, and drive continuous improvement Continual Professional Development (CPD): Active CPD to strengthen areas of expertise and develop competencies as an impactful Quality Professional Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.

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Responsibilities

Lead and manage all QA activities within the Genedata Expressionist Business Unit, ensuring alignment with regulatory and business objectives. Collaborate closely with cross-functional teams throughout the software lifecycle to embed quality and ensure compliance in regulated environments.